Vaccine trial restarts at KU School of Medicine-Wichita

As Pfizer this week announced that it has a strong candidate for a COVID-19 vaccine, the KU School of Medicine-Wichita Center for Clinical Research is restarting its role in the AstraZeneca vaccine trial.

It begs the question: Why are other trials proceeding if Pfizer’s vaccine is so promising?

“This is something I’m very passionate about,” said center director Tiffany Schwasinger-Schmidt, who also is a physician and an assistant professor of the Department of Internal Medicine. “We absolutely should keep going.”

She said Pfizer’s results are based on an extremely small number of test cases.

“It’s very, very small.”

Also, she said, “It’s very early data.”

There are a number of unanswered questions about the Pfizer results, such as ones related to variables that can make data seem better than it is. For instance, as COVID-19 cases rise, are these participants staying home more and limiting their exposure to the virus?

“That’s a big question off the Pfizer study,” Schwasinger-Schmidt said.

Even if, over time, the vaccine proves effective, she said there are so many people to treat worldwide that “it’s going to take a concerted effort.”

The AstraZeneca trial had a safety pause after a participant in Oxford, England — where the vaccine was developed — had what’s known as an adverse event and had to be hospitalized.

“All of the clinical trials researchers take that very seriously,” Schwasinger-Schmidt said. “We don’t want to do studies that risk people’s safety.”

However, it’s not uncommon for adverse events to happen during vaccine trials, which then pause for evaluation.

In this case, the FDA convened a board plus an independent safety board to look at data.

“They did a very deep dive,” Schwasinger-Schmidt said.

Although the investigation is ongoing, she said the FDA found it was safe to proceed with the trial.

Ready to enroll

Prior to the trial’s halt, Schwasinger-Schmidt said KU had been doing some of the final preparation work for the trial.

“We were ready to enroll when the pause was implemented.”

Now, it has 15 participants enrolled, but KU wants 200.

There are two ways to apply to participate in the trial.

One is by calling the Center for Clinical Research at (316) 293-1833 to be screened for eligibility. You must not have had a lab-certified case of COVID-19 to participate.

The other is through the COVID-19 Prevention Network website at www.coronaviruspreventionnetwork.org. Potential participants should select KUMC as the testing site and then answer a few questions.

Lake Waltanna residents Sara and Charles Lloyd read about the KU trial in The Wichita Eagle in August and called almost immediately.

Schwasinger-Schmidt happens to be their family physician, but that’s not why they wanted to be involved.

Sara Lloyd said she viewed participating as “payback time.”

She has a doctorate in educational leadership — she’s currently consulting as a professional coach for medical residents — and she said she relied on a lot of universities while doing her dissertation, and she’d like to give back.

Lloyd is 77, and her husband is 85.

“We’re in the zone of people who are vulnerable, so why wouldn’t we volunteer?” Charles Lloyd said.

The trial administers two vaccine shots and one placebo for every three participants. Lloyd said neither he nor his wife had any qualms about it.

“Absolutely not. We take flu shots every year.”

They answered screening questions, had blood drawn and had what Charles Lloyd called “a once-over type physical.”

Now, they fill out daily online surveys and will occasionally give more blood samples. The Lloyds are in a sub study. Participants in the main study don’t have to fill out anything daily.

The Lloyds said they are committed to the two-year trial even if a vaccine comes on the market before then.

“Each study probably brings up something that is helpful,” Sara Lloyd said.

Charles Lloyd said it’s unclear how long the Pfizer vaccine may be effective.

“And that’s part of the reason this study goes on for two years.”

At the end of the trial, if the Lloyds learn they were given the placebo, they will be able to then get the AstraZeneca vaccine.

Charles Lloyd said there’s a good chance they’ve already had it, which would be their preference.

“Sure, you’d like to get the vaccine, but you don’t have any choice,” he said. “It’s sort of a roll of the dice.”

Vaccine safety — and speed

In the race to get a vaccine — the government even calls its program Operation Warp Speed — everything may seem rushed, but Schwasinger-Schmidt said KU and others are still putting safety first.

“I just want to really reassure the public we are focused on their safety.”

She said Pfizer is seeking emergency approval for its vaccine, and the FDA is being appropriately cautious.

“We have to make sure that what we’re producing and putting out there is safe and effective.”

In August, Schwasinger-Schmidt said she thought it would take a year at the earliest before a vaccine could be approved. She said she doesn’t think Pfizer’s news changes that.

“I really do think it’s going to take up to a year for us to have those numbers,” she said of obtaining quality data.

She added, though, “The FDA may surprise us.”

In the end, Schwasinger-Schmidt said she thinks multiple vaccines will receive approval — and that’s a good thing.

“I just really want to get people protected,” she said.

“We all want a vaccine yesterday to be able to stop the devastation of this virus, but we need to do it in the right way . . . and make sure that it’s safe and effective.”